A Multi-Center Phase II Study to Compare MER-101 (20mg) Tablets To Intravenous Zometa 4mg in Male Bisphosphonate-Naive Hormone Refractory Prostate Cancer Patients
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Male
Hormone-Refractory Prostate Cancer
Male
Hormone-Refractory Prostate Cancer
Trial Information
A Multi-Center Phase II Study to Compare MER-101 (20mg) Tablets To Intravenous Zometa 4mg in Male Bisphosphonate-Naive Hormone Refractory Prostate Cancer Patients
Inclusion Criteria:
- Prostate Cancer with rising PSA levels after hormone treatment and bone metastasis
based on an X-ray.
Exclusion Criteria:
- Already be on a bisphosphonate treatment (Zometa, Fosamax, Actonel)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Effects on 4 markers of bone metabolism
Outcome Time Frame:
Weekly
Safety Issue:
No
Principal Investigator
Thomas W Leonard, PhD
Investigator Role:
Study Director
Investigator Affiliation:
Merrion Pharmaceuticals, LLC
Authority:
United States: Food and Drug Administration
Study ID:
MER-101-03
NCT ID:
NCT00636740
Start Date:
February 2008
Completion Date:
February 2009
Related Keywords:
- Hormone-Refractory Prostate Cancer
- Prostate cancer, hormone resistant, bisphosphonate
- Prostatic Neoplasms
Name | Location |
|---|---|
| Innovative Medical Research of South Florida, Inc. | Miami, Florida 33138 |
| Lakeland Regional Cancer Center | Lakeland, Florida 33805 |
| Birmingham Hematology & Oncology Associates, LLC | Birmingham, Alabama 35223 |
| Charleston Hematology Oncology Associates, PA | Charleston, South Carolina 29403 |
| Cancer Outreach Associates, P.C. | Abingdon, Virginia 24211 |
| Cancer Care of North Florida, P.A. | Lake City, Florida 32055 |
| Green Clinic, LLC | Ruston, Louisiana 71270 |
| New York Urological Associates, PC | New York, New York 10022 |
